First Patients Enrolled in Trial of Wearable Neurostimulation Device for Treating Essential Tremor
The Pacific Movement Disorders Center at Pacific Neuroscience Institute announced that the first patients have been enrolled into a trial of a wearable, external, and wireless neuromodulation device (Cala two; Cala Health, Burlingame, CA) for the treatment of essential tremor. The device is the size of a smart watch and delivers electric stimulation to the radial and median nerves and the wrist on the patient’s dominant hand.
In the PROSPECT study (NCT03597100) the device will be worn twice per day for 40 minutes with both objective and subjected measured endpoints of tremor improvement over a 3-month period. The trial is open to patients age 22 years or more with mild to severe essential tremor, and is open to people taking medication for essential tremor as well as those who are not. This study is a single-arm, prospective, multicenter study taking place at over 30 sites in the US.
"We are very excited about this trial for essential tremor patients with mild to severe disease," commented Melita Petrossian, MD, director of Pacific Movement Disorders Center and trial site principal investigator. Cala two represents a noninvasive treatment option that is highly accessible, especially for patients whose tremor is not improved by medication and who are not candidates for, nor are interested in, advanced treatment options such as deep brain stimulation (DBS) or focused ultrasound."